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This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.
A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians.
Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Bulgaria | Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE. |
| |
| Group Latvia | Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample | Other | Samples will be tested to determine the presence or absence of rotavirus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age. | At the time of enrollment of each subject (Day 0). |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings. | Day 0 - Day 14+5 (At the time of phone call follow-up contact). | |
| Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings. |
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Inclusion Criteria:
Exclusion Criteria:
• Child in care.
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Infants/children less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Burgas | 8000 | Bulgaria | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30335570 | Derived | Tafalla M, Gardovska D, Gopala K, Kozlovska L. Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis. Hum Vaccin Immunother. 2019;15(6):1272-1278. doi: 10.1080/21645515.2018.1534515. Epub 2018 Oct 31. | |
| 27622162 | Derived |
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| Data collection | Other | Log books |
|
| At the time of enrollment of each subject (Day 0). |
| Number of hospitalisations for RV GE and AGE, reported at the primary care settings. | At the time of phone call follow-up contact (14 to 19 days after enrollment). |
| Burgas |
| 8018 |
| Bulgaria |
| GSK Investigational Site | Dobrich | 9300 | Bulgaria |
| GSK Investigational Site | Pazardzhik | 4400 | Bulgaria |
| GSK Investigational Site | Pleven | 5800 | Bulgaria |
| GSK Investigational Site | Plovdiv | 4000 | Bulgaria |
| GSK Investigational Site | Rousse | 7000 | Bulgaria |
| GSK Investigational Site | Sliven | 8800 | Bulgaria |
| GSK Investigational Site | Sofia | 1505 | Bulgaria |
| GSK Investigational Site | Sofia | 1517 | Bulgaria |
| GSK Investigational Site | Sofia | 1528 | Bulgaria |
| GSK Investigational Site | Sofia | 1606 | Bulgaria |
| GSK Investigational Site | Stara Zagora | 6000 | Bulgaria |
| GSK Investigational Site | Varna | 9000 | Bulgaria |
| GSK Investigational Site | Veliko Tarnovo | 5000 | Bulgaria |
| GSK Investigational Site | Balvi | LV-4501 | Latvia |
| GSK Investigational Site | Bauska | LV-3901 | Latvia |
| GSK Investigational Site | Brocēni | LV-3851 | Latvia |
| GSK Investigational Site | Carnikava | LV-2163 | Latvia |
| GSK Investigational Site | Daugavpils | LV-5401 | Latvia |
| GSK Investigational Site | Daugavpils | LV-5410 | Latvia |
| GSK Investigational Site | Druva | LV-3862 | Latvia |
| GSK Investigational Site | Erglu Pagasts | LV-4840 | Latvia |
| GSK Investigational Site | Grobiņa | LV-3430 | Latvia |
| GSK Investigational Site | Ikšķile | LV-5052 | Latvia |
| GSK Investigational Site | Jelgava | LV-3001 | Latvia |
| GSK Investigational Site | Jelgava | LV-3002 | Latvia |
| GSK Investigational Site | Jelgava | LV-3007 | Latvia |
| GSK Investigational Site | Jelgava | LV-3008 | Latvia |
| GSK Investigational Site | Jēkabpils | LV-5201 | Latvia |
| GSK Investigational Site | Kuldīga | LV-3300 | Latvia |
| GSK Investigational Site | Liepāja | LV-3401 | Latvia |
| GSK Investigational Site | Limbaži | LV-4001 | Latvia |
| GSK Investigational Site | Līvāni | LV-5316 | Latvia |
| GSK Investigational Site | Madona | LV-4801 | Latvia |
| GSK Investigational Site | Ogre | LV-5001 | Latvia |
| GSK Investigational Site | Ozolnieki | LV-3018 | Latvia |
| GSK Investigational Site | Piņķi | LV-2107 | Latvia |
| GSK Investigational Site | Rēzekne | LV-4601 | Latvia |
| GSK Investigational Site | Rēzekne | LV-4604 | Latvia |
| GSK Investigational Site | Riga | LV-1001 | Latvia |
| GSK Investigational Site | Riga | LV-1002 | Latvia |
| GSK Investigational Site | Riga | LV-1010 | Latvia |
| GSK Investigational Site | Riga | LV-1011 | Latvia |
| GSK Investigational Site | Riga | LV-1012 | Latvia |
| GSK Investigational Site | Riga | LV-1024 | Latvia |
| GSK Investigational Site | Riga | LV-1050 | Latvia |
| GSK Investigational Site | Riga | LV-1063 | Latvia |
| GSK Investigational Site | Riga | LV-1082 | Latvia |
| GSK Investigational Site | Ropaži | LV-2135 | Latvia |
| GSK Investigational Site | Sigulda | LV-2150 | Latvia |
| GSK Investigational Site | Tukums | LV-3101 | Latvia |
| GSK Investigational Site | Valmiera | LV-4200 | Latvia |
| GSK Investigational Site | Valmiera | LV-4201 | Latvia |
| GSK Investigational Site | Vangaži | LV-2136 | Latvia |
| GSK Investigational Site | Ventspils | LV-3601 | Latvia |
| GSK Investigational Site | Ventspils | LV-3602 | Latvia |
| Tiholova M, Gopala K, Berberova M, Strokova-Stoilova M, Tafalla M. Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study. Germs. 2016 Sep 1;6(3):97-105. doi: 10.11599/germs.2016.1095. eCollection 2016 Sep. |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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